Analyte monitoring devices and methods therefor

ABSTRACT

Method and apparatus for performing a discrete glucose testing and bolus dosage determination including a glucose meter with bolus calculation function are provided.

RELATED APPLICATION

The present application is a continuation of U.S. patent application Ser. No. 13/556,142 filed Jul. 23, 2012, now U.S. Pat. No. 8,597,575, which is a continuation of U.S. patent application Ser. No. 11/396,182 filed Mar. 31, 2006, now U.S. Pat. No. 8,226,891, entitled “Analyte Monitoring Devices and Methods Therefor”, the disclosures of each of which are incorporated herein by reference for all purposes.

BACKGROUND OF THE INVENTION

In diabetes management, there exist devices which allow diabetic patients to measure the blood glucose levels. One such device is a hand-held electronic meter such as a blood glucose meter such as Freestyle® blood glucose monitoring system available from Abbott Diabetes Care Inc., of Alameda, Calif. which receives blood samples via enzyme-based test strips. Typically, the patient lances a finger or alternate body site to obtain a blood sample, applies the drawn blood sample to the test strip, and the strip is inserted into a test strip opening or port in the meter housing. The blood glucose meter converts a current generated by the enzymatic reaction in the test strip to a corresponding blood glucose value which is displayed or otherwise provided to the patient to show the level of glucose at the time of testing.

Such periodic discrete glucose testing helps diabetic patients take any necessary corrective actions to better manage diabetic conditions. Presently available glucose meters have limited functionalities (for example, providing the glucose value measured using the test strip and storing the data for subsequent recall or display) and do not provide any additional information or capability to assist patients in managing diabetes. For example, Type-1 diabetic patients who require periodic infusion or injection of insulin, typically use glucose meters in addition to, for example, wearing an external infusion device, or a pen type injection device. Also, in the case of external infusion devices, because of the strip port on the meter receives the test strip (which is generally not a water tight seal), it is not desirable to incorporate the discrete glucose meter functionalities to the housing of the external infusion devices.

With the decreasing cost of electronic components and a corresponding increase in data processing capabilities of microprocessors, computational capability of electronic devices has been rapidly increasing. However, currently available glucose meters are generally configured with limited functionalities related to discrete glucose testing. In view of the foregoing, it would be desirable to have a glucose meter, such as a blood glucose meter, with various functionalities. Of interest are glucose meters that are capable of providing bolus dosage calculation, and the like, and which incorporate additional features related to diabetes management.

SUMMARY OF THE INVENTION

In view of the foregoing, in accordance with the various embodiments of the present invention, there are provided methods and system for incorporating the bolus calculation function into a blood glucose meter device which may be configured to perform data analysis and management based on, for example, the glucose level detected using the glucose meter.

These and other objects, features and advantages of the present invention will become more fully apparent from the following detailed description of the embodiments, the appended claims and the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a glucose meter with bolus calculation function in accordance with one embodiment of the present invention;

FIG. 2 is a block diagram of the glucose meter with bolus calculation function of FIG. 1 in one embodiment of the present invention;

FIG. 3 is a flowchart illustrating the glucose level determination and bolus calculation procedure in accordance with one embodiment of the present invention;

FIG. 4 is a flowchart illustrating the bolus calculation procedure of FIG. 3 in accordance with one embodiment of the present invention; and

FIG. 5 is a flowchart illustrating the glucose level determination and bolus calculation procedure in accordance with another embodiment of the present invention.

DETAILED DESCRIPTION

As described in further detail below, in accordance with the various embodiments of the present invention, there are provided blood glucose meter devices that include bolus calculation functions and related data analysis capabilities incorporated in the glucose meter devices.

FIG. 1 shows a glucose meter with bolus calculation function in accordance with one embodiment of the present invention. Glucose meter with bolus calculation function 100 includes a housing 110 with a display unit 120 provided thereon. Also shown in FIG. 1 is a plurality of input buttons 130, each configured to allow the user of the glucose meter with bolus calculation function 100 to input or enter data or relevant information associated with the operation of the glucose meter with bolus calculation function 100. For example, the user of the glucose meter with bolus calculation function may operate the one or more input buttons 130 to enter a calibration code associated with a test strip 160 for use in conjunction with the glucose meter with bolus calculation function 100. Additionally, the user may operate the one or more input buttons 130 to adjust time and/or date information, as well as other features or settings associated with the operation of the glucose meter with bolus calculation function 100.

Referring back to FIG. 1, also shown is input unit 140 which, in one embodiment, may be configured as a jog dial, or the like, and provided on the housing 110 of the glucose meter with bolus calculation function 100. In one embodiment, as discussed in further detail below, the user or the patient may operate the input unit 140 to perform calculations and determinations associated with one or more bolus estimation function of the glucose meter with bolus calculation function 100. Also shown in FIG. 1 is a strip port 150 which is configured to receive the test strip 160 (with blood sample provided thereon) substantially in the direction as shown by the directional arrow 170.

In operation, when the test strip 160 with the patient's blood sample is inserted into the strip port 150 of the glucose meter with bolus calculation function 100, a micro processor or a control unit 210 (FIG. 2) of the glucose meter with bolus calculation function 100 may be configured to determine the associated glucose level in the blood sample, and display the determined glucose level on the display unit 120.

In addition, in accordance with the various embodiments of the present invention, the glucose meter with bolus calculation function 100 may be configured to automatically enter into a bolus determination mode to, for example, estimate the predetermined or pre-programmed bolus dosage amount based on information stored in the glucose meter with bolus calculation function 100 (such as the patient's insulin sensitivity, for example), and/or prompt the patient to provide additional information, such as the amount of carbohydrate to be ingested by the patient for determination of, for example, a carbohydrate bolus dosage determination. The patient may operate the input unit 140 in conjunction with the user interface menu provided on the display unit 120 to provide the appropriate information.

In another embodiment, the glucose meter with bolus calculation function 100 may be configured to prompt the patient to select whether to calculate a predetermined or preprogrammed bolus dosage amount such as, for example, a correction bolus or a carbohydrate bolus, following the display of the determined glucose level from the test strip 160. In this manner, in one embodiment of the present invention, the glucose meter with bolus calculation function 100 may be configured to automatically prompt the user or patient to select whether a bolus dosage determination is desired following a glucose testing using the test strip 160.

FIG. 2 is a block diagram of the glucose meter with bolus calculation function of FIG. 1 in one embodiment of the present invention. Referring to FIG. 2, the glucose meter with bolus calculation function 200 includes a controller unit 210 operatively coupled to a communication interface 220 and configured for bidirectional communication. The controller unit 210 is further operatively coupled to a test strip interface 230, an input section 240 (which, for example, may include the input unit 140 and the plurality of input buttons 130 as shown in FIG. 1), an output unit 250, and a data storage unit 260.

Referring to FIG. 2, in one embodiment of the present invention, the test strip interface 230 is configured to couple with the inserted test strip 160 for determination of the blood sample on the test strip 160. In addition, the test strip interface 230 may include an illumination segment which may be configured to illuminate the strip port 150 (FIG. 1) using a light emitting diode (LED), for example, during the test strip 160 insertion process to assist the user in properly and accurately inserting the test strip 160 into the strip port 150.

Moreover, in a further aspect of the present invention, the test strip interface 230 may be additionally configured with a physical latch or securement mechanism internally provided within the housing 110 of the glucose meter with bolus calculation function 100 (FIG. 1) such that when the test strip 160 is inserted into the strip port 150, the test strip 160 is retained in the received position within the strip port 150 until the sample analysis is completed. Examples of such physical latch or securement mechanism may include a uni-directionally biased anchor mechanism, or a pressure application mechanism to retain the test strip 160 in place by applying pressure on one or more surfaces of the test strip 160 within the strip port 150.

Referring back to FIG. 1, the output unit 250 may be configured to output display data or information including the determined glucose level on the display unit 120 (FIG. 1) of the glucose meter with bolus calculation function 100. In addition, in still a further aspect of the present invention, the output unit 250 and the input section 240 may be integrated, for example, in the case where the display unit 120 is configured as a touch sensitive display where the patient may enter information or commands via the display area using, for example, a stylus or any other suitable input device, and where, the touch sensitive display is configured as the user interface in an icon driven environment, for example.

Referring yet again to FIG. 2, the communication interface 220 in one embodiment of the present invention includes a wireless communication section configured for bi-directional radio frequency (RF) communication with other devices to transmit and/or receive data to and from the glucose meter with bolus calculation function 100. In addition, the communication interface 220 may also be configured to include physical ports or interfaces such as a USB port, an RS-232 port, or any other suitable electrical connection port to allow data communication between the glucose meter with bolus calculation function 100 and other external devices such as a computer terminal (for example, at a physician's office or in hospital environment), an external infusion device such as insulin pumps, or other devices that is configured for similar complementary data communication.

In one embodiment, the wireless communication section of the communication interface 220 may be configured for infrared communication, Bluetooth® communication, or any other suitable wireless communication mechanism to enable the glucose meter with bolus calculation function to communication with other devices such as infusion devices, analyte monitoring devices, computer terminals, communication enabled mobile telephones, personal digital assistants, or any other communication devices which the patient or user of the glucose meter with bolus calculation function 100 may use in conjunction therewith, in managing the treatment of the diabetic condition.

FIG. 3 is a flowchart illustrating the glucose level determination and bolus calculation procedure in accordance with one embodiment of the present invention. Referring to FIG. 3, a test strip is detected by the controller unit 210 (or the test strip interface 230) 310 of the glucose meter with bolus calculation function 100 (FIG. 1). Thereafter, the blood sample received from the inserted test strip 150 is analyzed 320 to determine the corresponding glucose level, and the determined glucose level is output 330 on the display unit 120 (FIG. 1) for example, in units of mg/dL.

Referring back to FIG. 3, after determining the glucose level and displaying the measured glucose level to the patient 330, a prompt command is generated and output to the patient to select if the bolus calculation is desired 340. More specifically, in one embodiment of the present invention, the controller unit 210 is configured to generate a command and display in the display unit 120 to query the user as to whether a bolus calculation determination is desired by the patient. Thereafter, a determination of whether or not the patient has selected to have the bolus dosage calculation performed by the controller unit 210 is made 350. In one embodiment, the patient may operate one or more of the input buttons 130 or the input unit 140 to select whether or not to have the bolus calculation performed.

Referring again to FIG. 3, if it is determined that the patient has selected not to have the bolus dosage determination performed, then the determined glucose value is stored 360, e.g., in memory of the meter, and the routine terminates. For example, in one embodiment, the controller unit 210 (FIG. 2) may be configured to store the determined glucose value in the data storage unit 260 with associated time and/or date information of when the glucose value determination is performed. In an alternate embodiment, the measured glucose value may be stored substantially concurrently with the display of the glucose value (for example, 330).

On the other hand, if it is determined that the patient has selected to have the bolus dosage calculation performed, the glucose meter with bolus calculation function 100 is configured to enter the bolus dosage determination mode 370, described in further detail below in conjunction with FIG. 4, where the desired type of bolus dosage is determined and provided to the patient.

FIG. 4 is a flowchart illustrating the bolus calculation procedure of FIG. 3 in accordance with one embodiment of the present invention. Referring to FIG. 4, when the glucose meter with bolus calculation function 100 (FIG. 1) enters the bolus dosage determination mode as described above, the controller unit 210 (FIG. 2) is configured to prompt the patient (for example, by displaying the options to the patient on the display unit 120 (FIG. 1)) to select the type of desired bolus dosage calculation 410. For example, the controller unit 210 may be configured to output a list of available bolus dosage calculation options including, for example, a carbohydrate bolus, a correction bolus, a dual or extended bolus, a square wave bolus, or any other suitable bolus calculation function which may be programmed into the glucose meter with bolus calculation function 100 (and for example, stored in the data storage unit 260).

Referring back to FIG. 4, after the patient selects the desired bolus dosage calculation in response to the prompt for bolus type selection 410, the selected bolus dosage calculation routine is retrieved 420 from the data storage unit 260, thereafter executed 430. In one embodiment, the execution of the selected bolus dosage calculation 430 may include one or more input prompts to the patient to enter additional information as may be required to perform the selected bolus dosage calculation.

For example, in the case of calculating a carbohydrate bolus, the patient may be prompted to provide or enter an estimate of the carbohydrate amount that the patient is planning on ingesting 430. In this regard, a food database may be stored in the data storage unit 260 or elsewhere for easy access (e.g., a PC, PDA, telephone, or the like and to which the meter may be coupled (e.g., wirelessly or by physical connection) to easily retrieve such information) to conveniently determine the corresponding carbohydrate amount associated with the type of food which the patient will be ingesting. Alternatively, the patient may provide the actual estimated carbohydrate count if such information is readily available by the patient.

Alternatively, in the case of calculating a dual bolus, the patient is prompted to provide a time duration information for the extended portion of the bolus dosage to be infused or otherwise provided to the patient. Similarly, the patient may further be prompted to provide insulin sensitivity information, and any other information as maybe necessary to determine the selected bolus dosage amount in conjunction with other relevant information such as insulin on board information, and the time of the most recently administered bolus (so as to provide a warning to the patient if a bolus dosage has been administered within a predetermined time period, and a subsequent administration of the additional bolus dosage may potentially be harmful).

Referring back to FIG. 4, after the execution of the selected bolus dosage calculation routine 430, the calculated bolus dosage amount is stored 440 in the data storage unit 260, and the calculated bolus dosage amount is output displayed to the patient 450 on the display unit 120 of the glucose meter with bolus calculation function 100, or audibly if the meter is so configured. In certain embodiments, storing and output displaying the calculated bolus dosage amount may be substantially concurrently performed, rather than sequentially.

FIG. 5 is a flowchart illustrating the glucose level determination and bolus calculation procedure in accordance with another embodiment of the present invention. Referring to FIG. 5, a test strip 160 is inserted into the strip port of the glucose meter with bolus calculation function 510, the blood sample on the test strip 160 is analyzed to determine the corresponding blood glucose level 520, and thereafter, output displayed 530.

Referring back to FIG. 5, a determination of the blood glucose level from the blood sample received from the test strip 160, is made 540. The controller unit 210 (FIG. 2) is configured to enter into the bolus dosage determination mode, and to execute pre-programmed or predetermined bolus calculation routine 550, and thereafter, output display the calculated bolus dosage amount 560. In this manner, in one embodiment of the present invention, the glucose meter with bolus calculation function 100 may be programmed or configured to automatically enter into the dosage determination mode upon completion of the blood sample analysis for glucose level determination.

In one embodiment of the present invention, the glucose meter with bolus calculation function 100 may be configured to execute different types of bolus dosage calculation based on the patient specified parameters. For example, the glucose meter with bolus calculation function 100 may be configured to perform a carbohydrate bolus determination when the test strip sample analysis is performed within a predetermined time period of a meal event. For example, the glucose meter with bolus calculation function 100 may be programmed by the patient to automatically select the carbohydrate bolus determination if the test strip blood sample analysis is performed within one hour prior to a meal time (which may be programmed into the glucose meter with bolus calculation function 100).

Accordingly, as described herein, embodiments of the present invention, method and apparatus for performing discrete glucose testing and bolus dosage determination are provided.

An apparatus including a glucose meter in one embodiment of the present invention includes a housing having a display unit disposed thereon, a strip port coupled to the housing and a controller unit coupled to the housing, a controller configured to process one or more signals associated with data received from the test strip, and a controller (the same or different controller from the controller described above) configured to determined a bolus dosage based on the data received from the test strip.

The controller may be configured to display the determined bolus dosage on the display unit, where the displayed bolus dosage may be one or more of an alphanumeric display, a graphical display, a video display, an audio display, a vibratory output, or combinations thereof.

In a further aspect, the controller unit may be configured to determine the bolus dosage substantially automatically after receiving the data from the test strip.

In one embodiment, the apparatus may include an output unit configured to provide one or more of an audible notification, a vibratory notification, or combinations thereof.

Moreover, the bolus dosage determined by the controller unit may include one or more of a carbohydrate bolus, a correction bolus, an extended bolus, a dual bolus, or combinations thereof.

The apparatus in yet another embodiment may include an input unit coupled to the housing, where the controller unit may be configured to determine the bolus dosage in response to a command received from the input unit.

The input unit may include one or more of an input button, a touch sensitive screen, a jog wheel, or combinations thereof.

Further, the data received from the test strip may correspond to an analyte level which, in one embodiment may include a measured glucose level of a patient.

A computer program product for use with a glucose meter in accordance with a further embodiment of the present invention includes a computer readable storage medium having a computer program stored thereon which controls the meter to calculate a bolus dosage based on glucose information received from the meter.

In one aspect, the glucose meter may be configured to display the calculated bolus dosage. The bolus dosage displayed on the glucose meter may be one or more of an alphanumeric display, a graphical display, a video display, an audio display, a vibratory output, or combinations thereof.

In a further aspect, the bolus dosage may include one or more of a carbohydrate bolus, a correction bolus, an extended bolus, a dual bolus, or combinations thereof.

Also provided are methods of analyte monitoring. Embodiments include receiving an analyte sample, determining an analyte level corresponding to the analyte sample, and determining a bolus dosage amount substantially immediately after the analyte level determination.

In one embodiment, the method may include displaying one or more of the bolus dosage, the analyte level, or combinations thereof. Determining a bolus dosage in some embodiments may be automatically performed after the analyte level determination.

The method may include generating one or more of an audible notification, a vibratory notification, a visual notification, or combinations thereof, associated with one or more of the determined bolus dosage, the determined analyte level, or combinations thereof.

The bolus dosage determined in one embodiment may include one or more of a carbohydrate bolus, a correction bolus, an extended bolus, a dual bolus, or combinations thereof.

The various processes described above including the processes performed by the processor unit 210 in the software application execution environment of the glucose meter device 200 including the processes and routines described in conjunction with FIGS. 3-5, may be embodied as computer programs developed using an object oriented language that allows the modeling of complex systems with modular objects to create abstractions that are representative of real world, physical objects and their interrelationships. The software required to carry out the inventive process, which may be stored in the storage unit 260 (FIG. 2) of the glucose meter with bolus calculation function 100, may be developed by a person of ordinary skill in the art and may include one or more computer program products.

A computer program product is also provided that is configured for use with a glucose meter. The program product includes a computer readable storage medium having a computer program stored thereon for calculating a bolus based on glucose information from the meter. For example, a meter controller may include a general purpose digital microprocessor or the like that may be programmed from such a computer readable medium carrying necessary program code for accomplishing the bolus function described herein. The programming may be provided remotely to the meter controller, e.g., through a communication channel, or previously saved in a computer program product such as memory or some other portable or fixed computer readable storage medium. For example, a magnetic or optical disk may carry the programming, which may be read by a reader of the meter and optionally stored in the meter memory of the meter. The computer program product may be any suitable product, such as a portable or fixed computer readable storage medium, including magnetic or optical disks or tape or RAM, or any other suitable device, either fixed or portable.

Various other modifications and alternations in the structure and method of operation of this invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. 

What is claimed is:
 1. An apparatus, comprising: a data storage unit for storing data including meal event information; a strip port configured to receive an analyte test strip; and a controller unit configured to detect when the analyte test strip is received in the strip port; wherein when the controller unit determines that the analyte test strip is received in the strip port within a predetermined time period of a meal event, the controller unit is further configured to automatically select a bolus determination mode to determine a bolus dosage.
 2. The apparatus of claim 1, further including an output unit operatively coupled to the controller unit, wherein the controller unit is further configured to output the determined bolus dosage on the output unit.
 3. The apparatus of claim 2, wherein the output unit is configured to provide one or more of a visual output, an audible output, a tactile output, or one or more combinations thereof.
 4. The apparatus of claim 1, wherein the determined bolus dosage includes one or more of a carbohydrate bolus, a correction bolus, an extended bolus, a dual bolus, or one or more combinations thereof.
 5. The apparatus of claim 1, further including an input unit operatively coupled to the controller unit, wherein the controller unit is configured to determine the bolus dosage in response to a command received from the input unit.
 6. The apparatus of claim 1, wherein the controller unit is further configured to determine an analyte level from an analyte test strip sample.
 7. The apparatus of claim 6, wherein the determined analyte level includes one or more of a glucose level or a ketone level.
 8. The apparatus of claim 1, further including a data communication unit operatively coupled to the controller unit, the data communication unit configured for one of uni-directional data communication or bi-directional data communication, wherein the data communication unit is configured to receive one or more signals associated with a monitored analyte level.
 9. The apparatus of claim 8, wherein the data communication unit is configured to receive the one or more signals associated with the monitored analyte level from an analyte sensor.
 10. The apparatus of claim 9, wherein the analyte sensor includes at least one working electrode including a mediator bonded to a polymer disposed on the working electrode.
 11. The apparatus of claim 10, wherein the at least one working electrode includes an analyte-responsive enzyme crosslinked with the polymer.
 12. The apparatus of claim 9, wherein the analyte sensor includes at least one working electrode including an analyte-responsive enzyme.
 13. The apparatus of claim 12, wherein the analyte-responsive enzyme is chemically bonded to the polymer.
 14. The apparatus of claim 12, wherein the at least one working electrode includes a mediator crosslinked with the polymer.
 15. A method, comprising: storing data including meal event information; detecting when an analyte test strip is received in a strip port; and automatically selecting a bolus determination mode to determine a bolus dosage when it is detected that the analyte test strip is received in the strip port within a predetermined time period of a meal event.
 16. The method of claim 15, further including outputting the determined bolus dosage on an output unit.
 17. The method of claim 16, further including outputting one or more of a visual output, an audible output, a tactile output, or one or more combinations thereof.
 18. The method of claim 15, wherein the determined bolus dosage includes one or more of a carbohydrate bolus, a correction bolus, an extended bolus, a dual bolus, or one or more combinations thereof.
 19. The method of claim 15, further including receiving a command from an input unit, wherein the bolus dosage is determined in response to the received command.
 20. The method of claim 15, further including determining an analyte level from an analyte test strip sample.
 21. The method of claim 20, wherein the determined analyte level includes one or more of a glucose level or a ketone level.
 22. The method of claim 15, further including receiving one or more signals associated with a monitored analyte level from an analyte sensor.
 23. The method of claim 22, wherein the analyte sensor includes at least one working electrode including a mediator bonded to a polymer disposed on the working electrode.
 24. The method of claim 23, wherein the at least one working electrode includes an analyte-responsive enzyme crosslinked with the polymer.
 25. The method of claim 22, wherein the analyte sensor includes at least one working electrode including an analyte-responsive enzyme.
 26. The method of claim 25, wherein the analyte-responsive enzyme is chemically bonded to the polymer.
 27. The method of claim 25, wherein the at least one working electrode includes a mediator crosslinked with the polymer. 